Stability in Biopharmaceutical Storage

Outsourcing stability storage is a highly efficient way to cut costs, improve services, and generate revenue by effective cost management. Switching to an outsourced stability storage facility could provide the benefit of increased customer satisfaction and improved efficiency. Outsourcing stability storage can free up aspects of a company's operations that might not be running efficiently. Finding the right outsourcing partner, however, can be quite a challenge. Consider the following before arriving at an off-site solution.

KEEPING STABILITY STORAGE IN-HOUSE IS COSTLY

Patrick Jackson

By its nature, any controlled environment storage facility needs a large investment in tailor-built premises. Floor space comes at a premium and much of the equipment needed has a large footprint, because it may have to be capable of accommodating bulk products. Typically, a resource with several million cubic litres of environmentally controlled storage space and storage suites that can house thousands of cubic meters of product is required.

Geographic location should also be considered. The location of the facility should be well away from natural disaster areas and be in a convenient location for shipping options. Proximity to major highways and airports can be a distinct advantage, particularly considering the speed at which new global markets are opening up.

Equipment investment

An average-sized storage room could cost anywhere between $63,000 to $190,000 to set up. A typical cabinet could cost upwards of $23,500. With separate rooms needed to suit different environmental conditions, costs can quickly mount up.

Walk-in stability room's cabinets and chambers should always be available, with additional chambers to be called upon for specific requirements such as retained samples, secondary storage, quarantine samples, freeze and thaw testing, and aerosol testing.

Ambient temperature and stability storage should be available, regardless of the size of product. Designing and building controlled-environment rooms and chambers is a skill that is developed over many years. Unique airflow technology systems should be incorporated to deliver definitive environmental conditions.

REGULATORY CONTROLS

Any facility working to cGMP guidelines should incorporate chambers and rooms that are built using the most modern techniques. They must be mapped and validated for pharmaceutical stability storage and biotech storage. Outsourcing companies can tailor these temperature and humidity controlled rooms and chambers to suit individual customer requirements as well as shelf life studies, intermediate testing, and accelerated testing per International Conference on Harmonization's (ICH) Q1A (R2) guideline (1).

The assessment of drug substance stability is a vital and essential aspect of the development of pharmaceutical products. Stability testing is capable of providing information on how environmental factors such as temperature, humidity, and light affect their quality over a period of time. Data derived from a stability study enables recommended storage conditions, re-test intervals, and shelf lives to be evaluated and established.

It is the norm for controlled environment rooms to be built and validated to provide climatic conditions specified in ICH guidelines. This should include equipment to allow for simulating conditions in all four climatic zones for long-term, intermediate, and accelerated testing. An outsourcing facility should have a comprehensive range of conditions including ICH Photostability Option 1 and Option 2 studies, as well as the capacity for customization. All staff should be fully accountable and provide a service that complies with regulatory requirements.

TAILORING OF SERVICES

An independent storage facility should be able to offer unique conditions, as there are many instances where drugs and drug-related products need to be stressed and tested in situations outside ICH guidelines. Any independent storage facility should offer conditions specifically suited to a company's product. It should meet the needs of companies that require off-site stability storage, redundant stability storage, short-term growth needs, back-up storage, or long-term stability storage.

Biopharmaceuticals, for instance, are particularly sensitive to environmental factors, making strict storage conditions necessary for the maintenance of biological activity and product integrity. The choice of temperature for the storage of biological, medical, and pharmaceutical materials is dependent upon the sample to be stored. An outsourcing facility should offer the option for storing materials under controlled ICH and non-ICH conditions in a purpose-designed storage suite. This service will provide an extremely cost-effective solution for controlled-environmental storage at temperatures that should range from minus 196 ºC to plus 55 ºC and relative humidities from 15% to 90%.

Pure DNA will exist for long periods at 4 ºC in buffer solution. For long-term storage, DNA is stored at minus 40 ºC, while proteins are better stored at minus 80 ºC and stem cells are stored at minus 196 ºC. A comprehensive cryobank will provide a solution for these and almost all other storage applications.

CRYOGENICS

There is an ever-increasing need for cutting edge cryogenics in today's controlled storage world. Cryopreservation is a process where cell (biology) or whole biological tissues are preserved by cooling to low sub-zero temperature, such as (typically) 77K or minus 196 °C (the boiling point of liquid nitrogen). At these low temperatures, any biological activity, including the biochemical reactions that would lead to cell death, is effectively stopped. However, when vitrification solutions are not used, the cell (biology) being preserved is often damaged due to freezing during the approach to low temperatures or warming to room temperature. These factors are further proof that it makes economic sense for pharmaceutical and related industries to adopt an outsourcing partnership for their complex cryobiological programs.

An outsourced controlled environment storage facility needs to provide a full range of services to store and manage biological materials at any given temperature. From bar-coding frozen vials through to relocating an entire repository, the quality policy should be reinforced by a positive commitment. This starts with an assurance that samples are stored in a high security facility with convenient access.